Product Quality Engineer II

We are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance.

Requirements

• Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
• Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
• Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations.
• Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
• Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
• Proficiency in developing or improving testing methods for complaint investigations and technical activities.
• Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements.

Benefits

• Annualized base salary range of $78,000-$122,100
• Bonus eligible